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Gn Resound A/S

Denmark · Ballerup

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

7listed device types

Class I 2Class II 5Class III 0

plus 20 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

9 including historic records

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

11device registrations

CLASS B 11

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

10active ARTG entries

IIa 10

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

16registrations

RURussiaRoszdravnadzor

22active registrations

Class 2a 22

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States20 registration records, 3 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: GN ReSound (Malaysia) Sdn Bhd. · GN RESOUND CHINA, LTD. · GN ReSound (Malaysia) Sdn. Bhd · GN RESOUND CANADA ATA RESOUND CANADA ATA RESOUND GN

Same-named companies — This database also contains companies with near-identical names: GN RESOUND CANADA ATA RESOUND CANADA ATA RESOUND GN, GN RESOUND CHINA, LTD., GN ReSound (Malaysia) Sdn Bhd.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12008 · K073636

12011 · K110932

12015 · K150171

FDA listed device types

Self-Fitting Air-Conduction Hearing Aid, Over The Counter 1Masker, Tinnitus 1Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter 1Self-Fitting Air-Conduction Hearing Aid, Prescription 1Hearing Aid, Air-Conduction With Wireless Technology, Prescription 1Face Plate Hearing Aid 1Hearing Aid, Air-Conduction, Prescription 1

Market	Identifier	Name	Class / date
US	K150171	Tinnitus Sound Generator Module	2015-05-14
US	K110932	TINNITUS SOUND GENERATOR MODULE	2011-05-03
US	K073636	TINNITUS SOUND GENERATOR MODULE	2008-03-13

Gn Resound A/S

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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